BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS LINEAR CUTTER

    MDR report key: 4220742 · Received November 3, 2014

    Report

    Report Number
    3005075853-2014-07565
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A TR45W CARTRIDGE NOT LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. EVENT COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED DURING THE FUNCTIONAL TESTING. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE DEVICE DID NOT COMPLETELY FIRE. THIS OCCURRED ON THE FIRST FIRING WITH A WHITE CARTRIDGE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701060 ETS LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4F14J

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - TR45W